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PhRMA Wants More User Fee Transparency

[ Price : $8.95]

PhRMA says FDA needs to be more transparent about its use of drug user fees and Congress needs to free the fees from sequestration...

Industry Ties May Lead to Broader Disease Definitions

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Researchers say there may be a connection between industry financial ties of members serving on expert guideline panels and broade...

Covis Wants FDA to Maintain Nilutamide BE

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Covis asks FDA to retain its recommendation for nilutamide bioequivalence testing

MannKind: Positive Phase 3 Results for Next Generation Afrezza

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MannKind Corp. has announces positive preliminary results from a Phase 3 clinical study involving Afrezza (insulin human [rDNA ori...

Medtronic PMA Module for IN.PACT Device

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Medtronic files its first PMA module for the IN.PACT Admiral drug-eluting balloon, intended for use in treating atherosclerotic le...

FDA Approves St. Jude MediGuide Ablation Catheter

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FDA approves a St. Jude Medical PMA for its MediGuide Enabled Ablation Catheter for treating specific irregular heartbeats.

Fluoroquinolone Drug Labels Getting More Risk Info

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FDA says it is requiring changes to fluoroquinolone drug labeling and Medication Guides to describe risk of peripheral neuropathy ...

Chelsea Therapeutics Corrects NDA Deficiencies

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Chelsea Therapeutics submits additional information to FDA to resolve certain technical deficiencies in its resubmitted NDA for No...

FDA Approves Stem Cell Study for Multiple Sclerosis

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FDA approves a Tisch MS Research Center IND to begin a Phase 1 trial using autologous neural stem cells for treating multiple scle...

FDA Grants Alnylam Orphan Status for Hemophilia Drug

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FDA grants Alnylam Pharmaceuticals an orphan drug designation for ALN-AT3 for treating hemophilia B.